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Completed

NCT Number: NCT04603053

Determining Effectiveness of an mHealth Intervention to Provide Adolescent CBT

Washington University will evaluate the acceptability and effectiveness of a mobile health (mHealth) intervention to provide cognitive behavioral therapy for adolescents with depression.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

In this pilot project, Washington University will start to evaluate CBot-A, a promising mHealth therapeutic intervention designed to deliver cognitive behavioral therapy (CBT) through an app on a phone or other mobile device. The evaluation will include a randomized trial among 40 adolescents diagnosed with depression and/or anxiety and will assess if CBot-A is usable by teens and likely to provide benefit, and acceptable to adolescents.

The primary outcome of depression and anxiety symptoms in adolescents will be assessed at 1 month and 3 months to check for any changes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adolescents 12-17 years of age and diagnosed with a major depressive disorder (MDD) and/or generalized anxiety disorder by their primary care provider within the past 3 months.

Exclusion criteria

Adolescents with the following conditions (identified by parental report) will be excluded:

  • Participated in formal CBT within the past 12-months
  • Diagnosed with severe depression
  • Diagnosed with the following anxiety disorders - obsessive-compulsive disorders, post-traumatic stress disorder, panic disorder, or specific phobias
  • A psychiatric hospitalization in the previous month
  • With significant comorbidities such that the PCP would refer to a mental health professional for treatment, including those with a substance use disorder or a psychotic illness.
  • Are not accompanied by a guardian to the diagnostic visit
  • Without access to a mobile device (cell phone or tablet) for regular use
  • Unable to read and write English
  • Participants may also be excluded at the discretion of the PI.

Treatment and study plan

mHealth app

Behavioral

Participants will receive access to CBot-A app for 12 weeks.

Primary outcomes

  1. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 1 month

    The PHQ-9 Adolescent Version will be used.This 9-item instrument scores from 0 to 27, with higher scores indicating more depressive symptoms

Secondary outcomes

  1. General Anxiety Disorder-7 (GAD-7)

    Time frame: 1 month

    This 7 item instrument scores from 0 to 21 with higher scores indicating more anxiety symptoms

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Washington University Institute of Clinical and Translational Sciences

Registry information

Official study title

Acceptability and Effectiveness of an mHealth Intervention to Provide Cognitive Behavioral Therapy (CBT) for Adolescents With Depression/Anxiety

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 26, 2020
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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